FDA product code · Dental
EBGCrown And Bridge, Temporary, Resin
Product code EBG covers Crown And Bridge, Temporary, Resin, a Class II device regulated under 21 CFR 872.3770. FDA has cleared 189 devices in this code, 2 of them in the last 12 months. Median review time across the 189 most recent decisions is 86 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.3770
- Review panel
- Dental
- Clearances
- 189
What is happening in EBG right now?
EBG (Crown And Bridge, Temporary, Resin) has two findings, most consequential first. 2 first-time filers in the last 12 months, Hangzhou SHINING3D Dental Technology Co., Ltd. and Liaoning Upcera Co., Ltd (K261261, K253380). The code is crowded, scoring 74 of 100 — 130 companies hold a clearance here and 2 arrived in the last 12 months (EBG:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K261261, K253380 |
| Crowding | Context | EBG:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in EBG?
FDA has cleared 189 devices under product code EBG since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | |
| K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd. | |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | |
| K242559 | Digital Temp | Sprintray, Inc. | |
| K231859 | PrimmaArt | Dentscare Ltda | |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH |
How long does FDA review take for EBG?
The median FDA review time for EBG is 86 days, measured across the 189 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EBG?
openFDA lists 4 recall records against product code EBG. A recall record covers one firm's corrective action and may span many device lots.
Z-0512-2021TerminatedTalladium Inc
Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make long-term temporary crowns and bridge restorations has incorrect label. label states Part no. 5336-B1 (98x20mm). However, the item inside the box was Part no. 4302-B1 (95x20mm). An incorrect label may result in compatibility issues when setting up the disc with milling machine fixtures due to size variation.
Z-0482-2010TerminatedJeneric/Pentron, Inc.
Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
Z-1041-04TerminatedLang Dental Mfg. Co., Inc.
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
Z-1042-04TerminatedLang Dental Mfg. Co., Inc.
The dental acrylic resin powders are contaminated with small black particles believed to be polyethylene.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EBG?
MAUDE holds 1 adverse-event reports naming product code EBG.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Who has entered EBG in the last year?
2 companies filed in EBG for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Hangzhou SHINING3D Dental Technology Co., Ltd. | K261261 | |
| Liaoning Upcera Co., Ltd. | K253380 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in EBG?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EBG?
Across the 189 most recent decisions, these applicants filed most often in EBG.
| Applicant | Recent clearances |
|---|---|
| GC America, Inc. | 6 |
| Ivoclar Vivadent, Inc. | 6 |
| Sybron Dental Specialties, Inc. | 6 |
| Dmg USA, Inc. | 5 |
| Voco GmbH | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch EBG
Get an email the morning anything changes in EBG — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.